Humes H David, Kleinman Nathan, Kammerer Jennifer, Iyer Sai Prasad N, Goldstein Stuart L, Kleinman Alec, Chung Kevin K, Thakar Charuhas V
Department of Internal Medicine (Nephrology), University of Michigan, Ann Arbor, MI, USA.
Kleinman Analytic Solutions LLC, Paso Robles, CA, USA.
J Med Econ. 2025 Dec;28(1):1467-1475. doi: 10.1080/13696998.2025.2550860. Epub 2025 Sep 4.
The Selective Cytopheretic Device for Pediatrics (SCD-PED) is a cell-directed extracorporeal therapy approved by the Food and Drug Administration through the humanitarian device exemption pathway for patients≥10kg, age≤22 years with acute kidney injury due to sepsis or a septic condition requiring antibiotics and on continuous renal replacement therapy (CRRT). We leveraged the Kids' Inpatient Database (KID) and SCD-PED study data to estimate hospitalization costs with and without SCD-PED therapy.
A cost regression model was built from KID hospitalizations (2019) that included patients aged 1-20 years with AKI receiving CRRT, total parenteral nutrition, KID mortality risk=4, KID severity=4, and hospital length of stay (LOS) ≤60 days. Data assessed as cost predictors included patient age, sex, vasopressor use, mechanical ventilation, sepsis, theoretical SCD-PED cost/number used, LOS, and death at hospital discharge. Differences in mean costs between a matched control cohort from the Prospective Pediatric CRRT registry (ppCRRT) and the SCD-PED study cohort were estimated from the model using SCD-PED study mortality rates and LOS reported in the SCD-PED studies.
Modeled hospitalization costs were $457,092 in KID cohort ( = 106), reflecting comparable heterogeneity and complexity. Modeled hospitalization costs were $389,451 in ppCRRT ( = 210). Median hospital LOS was lower in the SCD-PED group ( = 22): 28 days vs. 31 days in the control group, which despite the lower mortality rate, resulted in a lower estimated cost of $320,304, reflecting an estimated savings of $69,146 per hospitalization.
The model in the current study compares patients using SCD-PED to an external control cohort with similar characteristics, because controls were not examined in the original clinical studies. This study is not intended to be predictive of costs in other patient types or larger populations. Additional study is needed.
The SCD-PED is likely cost-beneficial in critically ill children with AKI requiring CRRT, including those with sepsis.
儿科选择性血细胞分离装置（SCD-PED）是一种细胞定向体外治疗设备，已通过美国食品药品监督管理局的人道主义器械豁免途径获得批准，适用于体重≥10kg、年龄≤22岁且因败血症或需要使用抗生素并接受持续肾脏替代治疗（CRRT）的脓毒症状况而导致急性肾损伤的患者。我们利用儿童住院数据库（KID）和SCD-PED研究数据来估算接受和未接受SCD-PED治疗的住院费用。
基于KID住院患者（2019年）建立成本回归模型，这些患者年龄在1至20岁之间，患有急性肾损伤且接受CRRT、全胃肠外营养，KID死亡风险=4，KID严重程度=4，住院时间（LOS）≤60天。作为成本预测指标评估的数据包括患者年龄、性别、血管升压药使用情况、机械通气、败血症、理论SCD-PED成本/使用数量、LOS以及出院时死亡情况。使用SCD-PED研究中报告的死亡率和LOS，从该模型估算前瞻性儿科CRRT注册研究（ppCRRT）的匹配对照队列与SCD-PED研究队列之间的平均成本差异。
KID队列中模拟的住院费用为457,092美元（n = 106），反映出相当的异质性和复杂性。ppCRRT中模拟的住院费用为389,451美元（n = 210）。SCD-PED组的中位住院LOS较低（n = 22）：28天，而对照组为31天，尽管死亡率较低，但估计成本较低，为320,304美元，反映出每次住院估计节省69,146美元。
本研究中的模型将使用SCD-PED的患者与具有相似特征的外部对照队列进行比较，因为原始临床研究中未对对照组进行研究。本研究并非旨在预测其他患者类型或更大人群的成本。需要进一步研究。
SCD-PED对于需要CRRT的急性肾损伤危重症儿童，包括患有败血症的儿童，可能具有成本效益。
